We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The Secore® HLA Sequencing System is intended for the identification and definition of Class I and Class II Human Leukocyte Antigens (HLA) and is for use in HLA typing. The Secore® HLA Sequencing System provides human histocompatibility information of HLA Class I (A, B, C) and Class II (DPB1, DQB1, and DRB) loci using genomic DNA isolated from whole blood samples.

HLA typing using the SeCore® HLA Sequencing Kits must be performed in the presence of an HLA Lab Director, Technical Supervisor and/or general Supervisor following accepted laboratory accreditation standards (ASHI). These products are for professional use only. This test must not be used as the sole basis for making clinical decisions.

The SeCore® HLA Sequencing System is intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA) for use in HLA typing. The SeCore® HLA Sequencing System provides human histocompatibility information of HLA Class I (A, B, and C) and Class II (DPB1, DQB1, and DR) Loci using genomic DNA isolated from whole blood specimens.

The test system uses polymerase chain reaction (PCR) technology, where denatured single stranded DNA is hybridized to an oligonucleotide primer. In an automated procedure, new strands of DNA are synthesized from the end of the primer by heat-resistant enzyme Taq Polymerase from a pool of deoxyribonucleotide triphosphates (dNTPs). The remainder of the reaction is treated with an enzyme cocktail consisting of exonuclease I and shrimp alkaline phosphatase which degrades unincorporated primers and dephosphorylates unused dNTPs.

The next step uses BigDye Terminator Sanger Sequencing Chemistry, which includes dye-labeled dNTPs that carry two dyes, one a donor, the other an acceptor. The donor dye collects laser light and transfers it to one of four different acceptor dyes. The resulting labeled DNA fragments are separated by capillary electrophoresis using the 3500 Dx/3500xL Dx Genetic Analyzer CS2 and are scanned, producing a primary sequencing data sample file (.ab1). The file is used by the uTYPE® Dx v1.0 HLA Sequence Analysis Software which matches the sequencing results to known HLA allele sequences.